Actively Recruiting
PROMOTE-FL: Pirtobrutinib and Mosunetuzumab to Enhance Treatment Efficacy for Patients With Relapsed/Refractory Follicular Lymphoma
Led by University of Washington · Updated on 2026-06-04
22
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how well pirtobrutinib and mosunetuzumab work together to treat patients with grade 1-3a follicular lymphoma (FL) that has returned after improvement or has not responded to previous treatments. Pirtobrutinib blocks a protein called Bruton tyrosine kinase (BTK) that helps cancer cells grow, while mosunetuzumab helps the immune system's T cells attack the lymphoma cells. This combination may kill more cancer cells and reduce some side effects related to T cell activation. Patients take pirtobrutinib by mouth once daily starting one week before mosunetuzumab treatment and continue for up to 52 weeks. Mosunetuzumab is given either under the skin or into a vein on days 1, 8, and 15 during the first treatment cycle, then on day 1 of each following 21-day cycle for up to 17 cycles unless the disease worsens or side effects become unacceptable. Those who achieve complete remission after 8 cycles stop mosunetuzumab. The study also involves collecting blood and swab samples, tissue biopsies, CT and PET/CT scans, and possibly bone marrow tests. Participants are closely monitored throughout treatment and afterward with follow-up visits 30 days after treatment ends and then periodically for up to 4 years. Researchers will assess outcomes such as complete remission rate after 8 cycles, progression-free survival, overall survival, and adverse events. Various laboratory tests, imaging, and questionnaires are used to track treatment effects, safety, and disease status over time.
CONDITIONS
Brief Title
Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to sign informed consent
- Age 18 years or older
- ECOG performance status of 0 or 1
- Histologically confirmed follicular lymphoma grades 1 to 3a
- Relapsed or refractory after at least two prior systemic therapies including anti-CD20 therapy
- Prior treatment side effects recovered to grade 1 or less except alopecia and grade 2 peripheral neuropathy
- At least one measurable lesion as defined by specific size criteria on imaging
- Liver enzymes and bilirubin within specified limits
- Platelet count at least 75,000/mm3 without recent transfusion
- Absolute neutrophil count at least 1000/mm3 without growth factors
- Hemoglobin at least 10 g/dL without recent transfusion
- Adjusted lower blood counts allowed with investigator approval
- Clotting times within normal limits
- Estimated creatinine clearance 30 mL/min or higher
- Negative pregnancy test if applicable
- Willingness to use effective contraception during and following treatment
You will not qualify if you...
- Disease progression within 6 months of prior BTK inhibitor therapy (BTKi refractory)
- Prior exposure to pirtobrutinib
- Prior CD3 T-cell engager therapy unless remission maintained for 24 months
- Recent use of monoclonal antibodies or systemic immunotherapies within specified timeframes
- Recent chemotherapy or anti-cancer agents within 4 weeks or 5 half-lives
- Recent radiotherapy within 2 weeks, with exceptions
- Recent stem cell transplant or CAR-T therapy within 60 days or with ongoing complications
- Prior solid organ transplant
- Unable to swallow oral medications
- History of bleeding disorders or major bleeding on prior BTKi
- Significant malabsorption or gastrointestinal conditions affecting drug absorption
- History of autoimmune diseases or certain immune disorders
- History of macrophage activation syndrome or HLH
- History of progressive multifocal leukoencephalopathy
- Severe allergic reactions to monoclonal antibodies or BTKi
- Recent or ongoing other malignancies except certain treated cancers
- History of central nervous system lymphoma or significant CNS diseases
- Significant cardiovascular disease or unstable heart conditions
- Active severe pulmonary disease
- Active uncontrolled infections or recent serious infections
- Known active hepatitis B or C infection or positive HIV status
- Need for therapeutic anticoagulation with warfarin or similar
- Pregnant or breastfeeding
- Recent live vaccination within 28 days of study drug start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants take pirtobrutinib orally once daily starting 7 days before beginning mosunetuzumab treatment.
1 visit to start medication
Duration - Up to 52 weeks
Participants receive pirtobrutinib orally once daily and mosunetuzumab given subcutaneously or intravenously in 21-day cycles. Mosunetuzumab is administered on days 1, 8, and 15 of the first cycle and then on day 1 of subsequent cycles, up to 17 cycles or until disease progression or unacceptable toxicity. Participants with complete remission after cycle 8 stop mosunetuzumab but continue pirtobrutinib up to 52 weeks. Various biopsies, blood and swab collections, CT and PET/CT scans may be performed throughout treatment.
Multiple visits every 7 to 21 days for medication administration and assessments
Duration - Up to 4 years
After completing study treatment, participants are followed up at 30 days post-treatment and then at standard of care intervals for up to 4 years to monitor health and survival.
1 visit at 30 days post-treatment and periodic visits thereafter
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
M
Mengyang Di, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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